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Emprove® Dossiers for Chemicals – Satisfy Your Regulatory Requirements

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Three Levels of Information Supporting Quality Risk Assessment
and Regulatory Requirements

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All our subscribers to the Emprove® Suite get online access to all dossiers of the entire Emprove® portfolio for two years.

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To address evolving regulatory requirements, we are constantly developing our Emprove® dossier library to better meet your regulatory challenges. The information on our Emprove® Evolve, Emprove® Essential and Emprove® Expert products is organized into three types of dossiers. Each dossier’s name indicates where it can be used to facilitate your raw material qualification, risk assessment and process optimization efforts.

  • The Material Qualification Dossier supports raw material qualification and speeds up drug filing preparation. It includes content on manufacturing processes, product characterization, regulatory certificates, stability summary, and more.
  • The Quality Management Dossier supports quality risk assessment according to ICH Q9 and EU 2015/C95/02 by offering extended information on the supply chain, Quality Management System as well as stability data.
  • The Operational Excellence Dossier supports process optimization and safety risk assessment activities around Elemental Impurities (ICH Q3D), Product Quality Reports, and Analytical Procedures and Technically Unavoidable Particle Profiles (if applicable).
Learn more about our different Emprove® Categories How Emprove® Dossiers for Chemicals can support you

Emprove® Dossier Library for Raw and Starting Materials

Dossier NamePurpose of DossierPriceContent
Material Qualification Dossier Information to start a raw material qualification

In line with CTD chapter 3 quality (adapted for excipients)		 Free of charge*
  • General information
  • Manufacture
  • Characterization
  • Control of drug substance
  • Reference standard
  • Materials
  • Container closure system
  • Stability summary
Quality Management Dossier

Demo Dossier

 Answers questions during quality risk assessment 5,500 €
  • Product quality self-assessment
  • Audit report summary
  • Supply chain information
  • Stability data**
Operational Excellence Dossier

Demo Dossier

 Supports process optimization 3,200 €
  • Product quality report
  • Elemental impurities information
  • Analytical procedure
Subscribe to Emprove® Suite Full Access to all dossiers of the Emprove® Library 10.000€, 20.000€, 45.000€ 
  • One time registration
  • Includes 5 email addresses per company
  • Access for 1, 2 or 5 years
  • Additional accesses can be purchased

*The Material Qualification Dossier is free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.

**Available for Emprove® Evolve, Emprove® Essential and Emprove® Expert products only

To learn more about our Emprove® dossiers for filters and single-use components please click here